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NCT06561048From ClinicalTrials.govRecruiting

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Angioimmunoblastic T-cell Lymphoma
  • Follicular T-Cell Lymphoma
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Systemic Anaplastic Large Cell Lymphoma
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, T-Cell

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Corvus Pharmaceuticals, Inc.
Enrolment target
150
Started
2 October 2024
Main results due
November 2027
Study sites
37
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Adult participants ≥18 years of age on the day of signing the informed consent form.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.
5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.
6. Life expectancy \>12 weeks.
7. Adequate organ function as determined by:

   * Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
   * Platelet count ≥ 100×10\^9/L (without transfusion)
   * Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug
   * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
   * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
   * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor
   * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
   * Serum albumin \> 2.5 g/dL
   * Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN
8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:

   * Grade ≤ 2 neuropathy
   * Alopecia and non-acute toxicities
   * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment
9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.
10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.

Exclusion Criteria:

1. Participants who have T-cell lymphoma with active central nervous system involvement.
2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
3. History of primary immunodeficiency or sold organ transplantation.
4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
5. Any active infection requiring IV therapy.
6. History of invasive prior malignancy that required systemic therapy within last 3 years.
7. Any condition that confounds the ability to interpret data from the study.
8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\]) or positive test for hepatitis C antibody.
9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.
10. Prior administration of an ITK inhibitor.
11. Participants who need immediate cytoreductive therapy.
12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.
13. History of allogeneic hematopoietic stem cell transplantation.
14. Candidate for hematopoietic stem cell transplantation at screening.
15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
16. Concurrent enrollment in another clinical study
17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.
18. Participants who cannot ingest medications orally or who have malabsorption.

What this study is about

In the sponsor’s own words, from the registry.

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Study sites(37)

  • City of Hope National Medical Center

    Duarte, California, United States

    Recruiting

  • University of California, Irvine

    Irvine, California, United States

    Recruiting

  • University of California San Francisco

    San Francisco, California, United States

    Recruiting

  • Yale University

    New Haven, Connecticut, United States

    Recruiting

  • Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine

    Miami, Florida, United States

    Recruiting

  • Emory University

    Atlanta, Georgia, United States

    Recruiting

  • North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC

    Chicago, Illinois, United States

    Recruiting

  • University of Iowa

    Iowa City, Iowa, United States

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, United States

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Recruiting

  • Roger Cancer Center University of Michigan Health

    Ann Arbor, Michigan, United States

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, United States

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, United States

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting

  • Weill Cornell Medicine

    New York, New York, United States

    Recruiting

  • North Carolina Cancer Hospital

    Chapel Hill, North Carolina, United States

    Recruiting

  • The Ohio State University

    Columbus, Ohio, United States

    Recruiting

  • Oregon Health & Science University; Knight Cancer Institute

    Portland, Oregon, United States

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, United States

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • University of Washington Fred Hutch Cancer Center

    Seattle, Washington, United States

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, United States

    Recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, Australia

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, Australia

    Recruiting

  • ICON Cancer Centre

    South Brisbane, Queensland, Australia

    Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, Australia

    Recruiting

  • Flinders Medical Center

    Bedford Park, South Australia, Australia

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania, Australia

    Recruiting

  • Box Hill Hospital

    Box Hill, Victoria, Australia

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, Australia

    Recruiting

  • Epworth Healthcare

    Richmond, Victoria, Australia

    Recruiting

  • Linear Clinical Research

    Perth, Western Australia, Australia

    Recruiting

  • BC Cancer Research Institute

    Vancouver, British Columbia, Canada

    Recruiting

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, Canada

    Recruiting

  • The Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

    Recruiting

Showing 37 of 37 sites. 37 of the 37 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06561048. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Other | Trialion